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Tislelizumab Combined APF Chemotherapy in the Treatment of Locally Advanced Head and Neck Tumors

ConditionHead and Neck Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

The goal of this clinical trial is to test in describe participant population. The main questions it aims to answer are:

1. evaluate the efficacy and safety of tislelizumab combined with APF sequential surgery or radical concurrent chemoradiotherapy in the treatment of locally advanced head and neck tumors. 2. the exploration of efficacy-related immune microenvironment genes Participants will receive tislelizumab combined with APF sequential surgery or radical concurrent chemoradiotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years old;

Histological or cytology-confirmed head and neck tumors (including oral, oropharynx, hypopharynx, larynx) squamous cell carcinoma, etc.;

Have at least one radiographically measurable lesion (RECIST 1.1 criteria);

The clinical stage is III-IVb (P16-) or II-III (P16+);

Disqualifiers

Received anti-tumor treatment in the past 6 months, including radiotherapy and chemotherapy, surgery, immunotherapy Wait;

Previously or concurrently suffering from other malignant tumors (except for malignant tumors that have been cured and survived for more than 5 years without cancer, such as skin basal cell carcinoma, cervical carcinoma in situ, superficial bladder cancer, and thyroid papillary carcinoma, etc.);

There is distant metastasis;

Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); but excludes autoimmune-mediated hypothyroidism on stable doses of thyroid replacement hormone; type 1 diabetes on stable doses of insulin; vitiligo or resolved childhood asthma/allergies, Patients who do not require any intervention after adulthood;

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU

    Drug

    evaluate the efficacy and safety of immunotherapy combined with chemotherapy

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: immunotherapy combined with chemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change of pathological examination

Changes in pathologic examination before treatment and after 3-cycle induction therapy were evaluated to derive the number and proportion of patients with pathological complete remission

Time frame
Change from Baseline pathologic examination at the end of Cycle 3 (each cycle is 21 days)
2

Change of tumor size

imaging (MRI or CT) assessment according to RECIST v1.1 was performed and documented during follow-up as required

Time frame
Change from baseline tumor size at the end of Cycle 3 (each cycle is 21 days)

Secondary outcomes

1

Security assessment

according to the NCI-CTCAE 4.0 adverse reaction evaluation criteria

Time frame
At the end of Cycle 3 (each cycle is 21 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Lead sponsor

Source ClinicalTrials.gov
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